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Trial registered on ANZCTR


Registration number
ACTRN12625000048482
Ethics application status
Approved
Date submitted
11/12/2024
Date registered
20/01/2025
Date last updated
20/01/2025
Date data sharing statement initially provided
20/01/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Outcomes of surgery using Zeiss Quatera 700 in adults with complex cataract in Broome, Western Australia.
Scientific title
Impact of surgery with Post-Market Zeiss Quatera 700 on central endothelial cell count in adults with complex cataract in Broome, Western Australia.
Secondary ID [1] 313466 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cataract 335869 0
Condition category
Condition code
Eye 332454 332454 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Complex cataract surgery with Zeiss Quatera 700
Cataract surgery will be performed by an Ophthalmologist at the Broome Regional Hospital with the Zeiss Quatera 700 machine. Patients will have cataract surgery performed with Quatera 700 regardless of their participation in this study. The Zeiss Quatera 700 is an approved cataract surgery machine, therefore Ophthalmologists require no additional training to use it. However, a Zeiss rep was present for the first few surgical lists for each surgeon in April and May 2023 to troubleshoot and help establish surgeon preference parameters.

Under routine care, patients undergoing cataract surgery attend one pre-operative appointment and post-operatively will have a follow-up the next day and a month later. As part of this study, participants will be asked to attend an additional three-month follow-up visit. These clinic visits will be conducted face-to-face by Lions Outback Vision Ophthalmologists or Registered Medical Officers, although the doctor may not be the one that performed the surgery. Further details including procedures undertaken at these visits are outlined below.

Visit 1, 60 minutes at LOV clinic, pre-operative: Visual acuity - aided, unaided, pinhole; intraocular pressure (IOP); biometry; slit lamp examination; fundus examination, specular microscopy.
Surgical visit, up to 30 minutes for surgery and 4-6 hours for hospital visit at Broome Hospital: Cataract surgery performed by an Ophthalmologist at the Broome Regional Hospital with the Zeiss Quatera 700 machine.
Visit 2, 30 minutes at LOV clinic, 1 day post-operative: Uncorrected distance visual acuity (UDVA), IOP, pachymetry.
Visit 3, 45 minutes at LOV clinic, 1 Month post-operative: UDVA, IOP, optical coherence tomography (OCT) macula, pachymetry, specular microscopy.
Visit 4, 45 minutes at LOV clinic, 3 Month post-operative: UDVA, IOP, OCT macula, pachymetry, specular microscopy.

Adherence to the intervention will be assessed through review of the electronic medical record.
Intervention code [1] 330038 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339997 0
Central endothelial cell count
Timepoint [1] 339997 0
pre-operative assessment; one-month post-operation; and three months post-operation
Secondary outcome [1] 442835 0
Phaco energy
Timepoint [1] 442835 0
At the start of the surgical procedure
Secondary outcome [2] 442836 0
Surgical technique used
Timepoint [2] 442836 0
At the end of the surgical procedure
Secondary outcome [3] 442837 0
Total Phaco Time
Timepoint [3] 442837 0
At the end of the surgical procedure
Secondary outcome [4] 442838 0
Effective Phaco Time
Timepoint [4] 442838 0
At the end of the surgical procedure
Secondary outcome [5] 442839 0
Volume of Aspirated Fluid
Timepoint [5] 442839 0
At the end of the surgical procedure
Secondary outcome [6] 442840 0
Presence of complications including anterior chamber collapse during surgery, posterior capsular rent, retained lens fragment, placement of sulcus intraocular lens, endophthalmitis
Timepoint [6] 442840 0
At the end of the surgical procedure, 1-day, 1-month and 3-month post-operation.
Secondary outcome [7] 442841 0
Uncorrected distance visual acuity (UDVA)
Timepoint [7] 442841 0
Day 1 and 1-month post-operation
Secondary outcome [8] 442842 0
Corneal thickness
Timepoint [8] 442842 0
Day 1 and 1-month post-operation

Eligibility
Key inclusion criteria
Adults (18 years and over) with complex cataract. This includes those with cataract following traumatic ocular injury resulting in zonular dehiscence, or those with pseudoexfoliation syndrome.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Those with pre-operative central endothelial cell count of less than 1500 cells/mm2
2. Those with prior corneal disease including corneal scars, severe dry eye syndrome
3. Those with prior pupillary abnormalities
4. Those with very guarded visual prognosis, e.g. no perception of light and/or relative afferent pupil defect

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis
Clinical characteristics and demographic information will be summarised by mean (standard deviation) or median (interquartile range) depending on the continuous variables’ distribution and frequency (percentage) for categorical variables. Primary and secondary outcome continuous variables with repeated measurements will be assessed with the paired t-test. Other variables will be summarised with descriptive statistics.

As this is an exploratory analysis, sample size calculation was not performed. Participants with missing data will be excluded from analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/02/2025
Actual
Date of last participant enrolment
Anticipated
2/02/2026
Actual
Date of last data collection
Anticipated
4/05/2026
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 317903 0
Commercial sector/Industry
Name [1] 317903 0
Carl Zeiss Meditec, Inc.
Country [1] 317903 0
United States of America
Primary sponsor type
Individual
Name
Dr Angus Turner, Lions Eye Institute
Address
Country
Australia
Secondary sponsor category [1] 320246 0
None
Name [1] 320246 0
Address [1] 320246 0
Country [1] 320246 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316591 0
The University of Western Australia Human Research Ethics Committee
Ethics committee address [1] 316591 0
Ethics committee country [1] 316591 0
Australia
Date submitted for ethics approval [1] 316591 0
16/09/2024
Approval date [1] 316591 0
27/09/2024
Ethics approval number [1] 316591 0
2024/ET000612

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 138346 0
Dr Angus Turner
Address 138346 0
Lions Eye Institute, 45 Frederick Street, Broome WA 6725
Country 138346 0
Australia
Phone 138346 0
+61422279179
Fax 138346 0
Email 138346 0
angus.turner@lei.org.au
Contact person for public queries
Name 138347 0
Emma Doulgas
Address 138347 0
Lions Eye Institute, 45 Frederick Street, Broome WA 6725
Country 138347 0
Australia
Phone 138347 0
+61 63820532
Fax 138347 0
Email 138347 0
emma.douglas@lei.org.au
Contact person for scientific queries
Name 138348 0
Angus Turner
Address 138348 0
Lions Eye Institute, 45 Frederick Street, Broome WA 6725
Country 138348 0
Australia
Phone 138348 0
+61422279179
Fax 138348 0
Email 138348 0
angus.turner@lei.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.